Diagnostic Kits/Effects of patents and licenses on the provision of clinical genetic testing services
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Cho, M.K. et al., 2003. Effects of patents and licenses on the provision of clinical genetic testing services. The Journal of Molecular Diagnostics: JMD, 5(1), 3-8. Available at: http://jmd.amjpathol.org/cgi/content/full/5/1/3 [Accessed August 10, 2009].
- Cho et al. 2003 - This paper addresses the risks associated with the expansion of patents on genetic sequences as it relates to the availability of genetic testing services and the viability of continued genetic testing research. The telephone survey conducted sought to survey clinical labs who performed genetic tests for research purposes. While the sample was limited to members of the Association for Molecular Pathology those mentioned on the GeneTests.org website, one hundred and thirty two lab directors were interviewed for the survey. Probably most importantly the study found, “Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license.” (Cho et al. 2003). Perhaps even more startling, “as a result of patent- or license-holders exercising their intellectual property rights, one-quarter of the laboratory directors in our sample stopped performing a genetic test that they had been offering.” (Cho et al. 2003). The study shows that now only are labs declining to develop new tests but they are stopping their current genetic test offerings as a reaction to patent or license holders. The paper concludes that the effects of genetic patenting are significant to the development and availability of genetic tests.
- An interesting proposition raised in the analysis was the role of the Bayh-Dole Act. The patent holders enforcing their patents were heavily represented by universities with patents resulting from government-sponsored research. In fact, “The majority of the patent holders enforcing their patents were universities or research institutes, and more than half of their patents resulted from government-sponsored research” (Cho et al. 2003). The paper suggests that the Bayh-Dole Act may not be enhancing technology transfer in the area of genetic testing.